Trial registration number
|
NCT04775069 |
Full text link
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04775069
|
First author
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Humanity & Health Medical Group Limited
|
Contact
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Not reported
|
Registration date
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
2021-03-01
|
Recruitment status
Last imported at : Oct. 5, 2023, 4 p.m.
Source : ClinicalTrials.gov
|
Completed
|
Study design
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
nonRCT
|
Allocation
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Non-randomized
|
Design
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Open label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
single-center
|
Study aim
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Prevention
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
subjects with chronic liver disease (cld) at the humanity and health medical group and eligible for the hk government vaccination programme;
able to understand and sign informed consent.;
underlying cld- defined as patients with chronic hepatitis b or c infections, liver cirrhosis, metabolic associated liver disease, hepatocellular carcinoma, alcoholic liver disease, autoimmune hepatitis, hemochrombtosis.
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
|
patients contraindicated for the covid -19 vaccination program due to uncontrolled co-morbitities;
past allergies to other vaccines;
pregnant subjects.
|
Number of arms
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
3
|
Funding
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Humanity & Health Medical Group Limited
|
Inclusion age min
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Hong Kong
|
Type of patients
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
High risk patients
|
Severity scale
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
N/A
|
Total sample size
Last imported at : Oct. 5, 2023, 4 p.m.
Source : ClinicalTrials.gov
|
232
|
primary outcome
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Antibody response
|
Notes
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
Phase 4
|
Arms
Last imported at : March 2, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "2", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
|